Vascular access kits and methods

ABSTRACT

Kits carrying various components and devices are provided for use in obtaining access to a patient&#39;s vascular system. Various methods and procedures may be used to treat both emergency and more routine conditions using the contents of such kits. For example, such kits may contain various types of intraosseous (IO) devices including, but not limited to, drivers, penetrator assemblies, IO needles and other related components. Intravenous (IV) devices such as syringes, needles, IV bags, tubing and other related components for use in obtaining access to portions of a patient&#39;s vascular system may be included. Various types of connectors for communicating fluids with and/or monitoring a patient&#39;s vascular system may be provided. Such kits may contain medications, drugs and fluids used to treat a wide variety of both acute and chronic diseases and conditions.

RELATED APPLICATION

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/675,246, filed Apr. 27, 2005, and entitled“Vascular Access Kit.”

This application is a U.S. continuation-in-part application of U.S.application Ser. No. 10/449,503 entitled “Apparatus And Method ToProvide Emergency Access To Bone Marrow”, filed May 30, 2003 now U.S.Pat. No. ______, which claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/384,756, filed May 31, 2002.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present disclosure is related to U.S. patent application Ser. No.10/449,503 filed May 30, 2003; U.S. patent application Ser. No.10/448,650 filed May 30, 2003; U.S. patent application Ser. No.10/449,476 filed May 30, 2003; and U.S. patent application Ser. No.10/987,051 filed Nov. 12, 2004.

TECHNICAL FIELD

The present disclosure is related to apparatus and methods to obtainvascular access and more particularly to a kit, apparatus contained inthe kit and associated methods which may be used to provide access tobone, bone marrow and other portions of a patient's vascular systemusing the apparatus.

BACKGROUND

Every year, millions of patients are treated for life threateningemergencies in the United States. Such emergencies include shock,trauma, cardiac arrest, drug overdoses, diabetic ketoacidosis,arrhythmias, burns, and status epilepticus just to name a few. Forexample, according to the American Heart Association, more than1,500,000 patients suffer from heart attacks (myocardial infarctions)every year, with over 500,000 of them drying from its devastatingcomplications. In addition, many wounded soldiers die unnecessarilybecause intravenous (IV) access cannot be achieved in a timely manner.Many soldiers die within an hour of injury, usually from severe bleedingand/or shock.

An essential element for treating all such emergencies may be the rapidestablishment of an IV line in order to administer drugs and fluidsdirectly into the circulatory system. Whether in the ambulance byparamedics, in the emergency room by emergency specialists or on thebattlefield by an Army medic, a common goal is to start an IV as soon aspossible to administer life saving drugs and fluids. To a large degree,the ability to successfully treat such critical emergencies may bedependent on the skill and luck of the operator in a accomplishingvascular access. While it may be relatively easy to start an IV on somepatients, doctors, nurses and paramedics often experience difficultyestablishing IV access in approximately twenty (20%) percent ofpatients. The success rate on the battlefield is often much lower whereArmy medics may only be about twenty-nine (29%) percent successful instarting an IV line during emergency conditions in the field. Thesepatients are probed repeatedly with sharp needles in as attempt to solvethis problem and may require an invasive procedure to finally establishan intravenous route.

In the case of patients with chronic disease or the elderly, theavailability of easily accessible veins may be depleted. Other patientsmay have no available IV sites due to anatomical scarcity of peripheralveins, obesity, extreme dehydration or previous IV drug use. For thesepatients, finding a suitable site for administering life saving drugsmay become a difficult and frustrating task. It is generally well knownthat patients with life threatening emergencies have died because accessto the patient's, vascular system with life saving IV therapy wasdelayed or simply not possible.

An accepted alternative route to give IV medications and fluids isthrough bone marrow by providing intraosseous (IO) access. Drugs andother fluids may enter a patient's vascular system just as rapidly viathe intraosseous route as when given intravenously. Bone and associatedbone marrow may be considered a large, non-collapsible vein. The IOroute has been used for alternative emergency access in pediatricpatients, whose bones are soft enough to permit manual insertion of IOneedles.

SUMMARY

The present disclosure relates to kits, apparatus contained in such kitsand associated procedures to obtain access to a patient's vascularsystem. For Home embodiments such kits may include intravenous (IV)access devices and intraosseous (IO) access devices. Such kits may beused in both emergency situations or more routine procedures associatedwith treating chronic conditions. The present disclosure may provideapparatus and methods to establish vascular access during treatment of apatient at a wipe variety of locations and facilities including, hut notlimited to, accident sites, emergency rooms, battlefields, emergencymedical services (EMS) facilities, oncology treatment centers, chronicdisease treatment facilities and veterinary applications.

Technical benefits of some embodiments may include providing portablekits with devices and components for rapid penetration of bone and bonemarrow to provide access to a patient's vascular system.

Technical benefits of some embodiments may include devices andcomponents for rapid penetration of bone and associated bone marrow.Such devices and components may be placed in a kit for use in accessinga patient's vascular system.

Technical benefits or some embodiments may include obtaining fast,inexpensive access to a patient's vascular system with minimal risk.Apparatus and methods incorporating teachings of the present disclosuremay be used to provide IO and IV access so that drugs and/or fluids canbe injected into associated bone marrow.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete and thorough understanding of various embodiments andadvantages thereof may be acquired by referring to the followingdescription taken in conjunction with the accompanying drawings, inwhich like reference numbers indicate like features, and wherein:

FIG. 1A in a schematic drawing showing an isometric view or one exampleof a kit which may be used to obtain access to a patient's vascularsystem in a first, closed position;

FIG. 1B is a schematic drawing with portions broken away showing oneexample of a breakable seal which may be used to indicate status of thekit of FIG. 1B;

FIG. 2A is a schematic drawing showing an isometric view of the kit inFIG. 1A in an open position along with examples of intraosseous andintravenous devices and components disposed therein;

FIG. 2B is a schematic drawing showing one side of a divider or panelwhich may be disposed in the kit of FIG. 2A along with examples ofintraosseous and intravenous devices and components attached thereto;

FIG. 3 is a schematic drawing showing an isometric view of one exampleof a securing device which may be installed in a kit to releasably holda drive in accordance with teachings of the present disclosure;

FIG. 4 is a schematic drawing showing one example of a powered driverand penetrator assembly which may be included in a kit in accordancewith teachings of the present disclosure;

FIG. 5 is a schematic drawing showing an isometric view of one exampleof a powered driver and securing device releasably engaged with eachother in accordance with teachings of the present disclosure;

FIG. 6 is a schematic drawing showing an isometric view of one exampleof a kit in a second, open position with a powered driver installed in asecuring device operable to recharge a battery carried within thepowered driver in accordance with teachings of the present disclosure;

FIG. 7A is a schematic drawing showing another example of a kit in afirst, closed position incorporating teachings of the presentdisclosure;

FIG. 7B is a schematic drawing showing an isometric view of the kit ofFIG. 7A in a second, open position;

FIG. 8 is a schematic drawing in section showing an intraosseous deviceinserted into bone marrow of a patient after using various devices andcomponents carried in a kit in accordance with the teachings of thepresent disclosure;

FIG. 9 is a schematic drawing in elevation with portions broken awayshowing one example of a strap and supporting structure which may becarried in a kit and used to position an intraosseous device at aselected insertion site;

FIG. 10 is a schematic drawing showing a plan view with portions brokenaway of another example of a strap and supporting structure which may becarried in a kit and used to position an intraosseous device at aselected insertion site; FIG. 11 is a schematic drawing in section andin elevation showing an intraosseous device inserted into bone marrow ofa patient along with another example of a strap and supporting structurewhich may be carried in a kit in accordance with teachings of thepresent disclosure;

FIG. 12 is a schematic drawing in section showing an intraosseous deviceinserted into bone narrow of a patient along with another example of astrap and supporting structure which may be carried in a kit inaccordance with teachings of the present disclosure;

FIG. 13 is a schematic drawing in section showing an intraosseous deviceinserted into bone narrow of a patient along with another example of astrap and supporting structure which cay be carried in a kit inaccordance with teachings of the present disclosure;

FIG. 14 is a schematic drawing in section showing another example of astrap and supporting structure which may be satisfactorily used toposition an intraosseous device at a selected insertion site;

FIG. 15 is a schematic drawing in section with portions broken away ofthe strap and supporting structure of FIG. 14;

FIG. 16 is a schematic drawing showing an isometric view with portionsbroken away of the strap and supporting structure of FIGS. 14 and 15releasably attached to the leg of a patient proximate the tibia;

FIG. 17 is a schematic drawing showing another example of a powereddriver which may be carried in a kit incorporating teachings of thepresent disclosure along with a strap and supporting structure for anassociated intraosseous device;

FIG. 18A is a schematic drawing showing an exploded view of a manualdriver and associated intraosseous device which may be carried in a kitin accordance with teachings of the present disclosure;

FIG. 18B is a schematic drawing showing an isometric view of a containerwith one example of an intraosseous device disposed therein; and

FIG. 19 is a schematic drawing showing another example of a manualdriver which may be carried in a kit in accordance with teachings of thepresent disclosure.

DETAILED DESCRIPTION

Preferred embodiments and associated features and benefits may beunderstood by reference to FIGS. 1A through 19 wherein like referencenumbers indicate like features.

Vascular system access is essential for the treatment of many seriousdiseases and conditions and almost every serious emergency. Yet, manypatients experience extreme difficulty obtaining timely treatmentbecause of the inability to obtain or maintain venous access. Theintraosseous (IO) space provides a direct conduit to systemiccirculation and, therefore, is an attractive route to administerintravenous (IV) drugs and fluids. Rapid IO access offers great promisefor almost any serious emergency than requires IV access to administerlife saving drugs or fluids when traditional IV access is difficult orimpossible.

IO access may be used as a “bridge” (temporary fluid and drug therapy)during emergency conditions until conventional IV sites can be found andutilized. Thus often occurs because fluids and/or medication providedvia an IO access may stabilize a patient and expand veins and otherportions of a patient's vascular system. Kits with IO devices andassociated procedures incorporating teachings of the present disclosuremay become the standard of care for administering medications and fluidsin situations when IV access is difficult or not possible.

IO access generally provides rapid and reliable vascular access toadminister life saying drugs or fluids, when traditional IV access isdifficult or impossible. Such emergencies include shock, trauma, cardiacarrest, drug overdoses, diabetic coma, burns, dehydration, seizures,allergic reactions, and arrhythmias. There are more than 100 millionvisits to emergency rooms annually. Statistics allow that vascularaccess may be difficult or impossible in 4 million patients annually.

Intraosseous access may be used as a “routine” procedure with chronicconditions which substantially reduce or eliminate the availability ofconventional IV sites. Examples of such chronic conditions may include,but are not limited to, dialysis patients, seriously ill patients inintensive care units and epilepsy patients. Kits and intraosseousdevices incorporating teachings of the present disclosure may be quicklyand safely used to provide IO access to a patient's vascular system indifficult cases such as status epilepticus to give medical personnel anopportunity to administer crucial medications and/or fluids. Furtherexamples of such acute and chronic conditions are listed near the end ofthis written description.

The term “driver” may be used in this application to include any type ofpowered driver or manual driver satisfactory for inserting anintraosseous device such as a penetrator assembly or IO needle intoselected portions of a patient's vascular system. Various techniques maybe satisfactorily used to releasably engage or attach an IO deviceand/or penetrator assembly with manual drivers and powered drivers.Various features and benefits of the present disclosure may be describedWith respect to kit having a driver to insert an intraosseous (IO)device into hone marrow of a patient at a selected insertion site.However, a kit with devices and components incorporating teachings ofthe present disclosure may be satisfactorily used to access variousportions of a patient's vascular system. The present disclosure is notlimited to IO devices and procedures.

The term “kit” may be used in this application to describe a widevariety of bags, containers, carrying cases and other portableenclosures which may be used to carry and store intraosseous devicesand/or intravenous devices along with related components andaccessories. Such kits and their contents along with applicableprocedures may be used to provide access to a patient's vascular systemin accordance with teachings of the present disclosure.

The present disclosure includes a wide variety of kits, devices andassociated components which may be used to obtain vascular access to apatient. In some embodiments, such kits may include apparatus operableto access a patient's hone marrow using a driver, an intraosseous needleand one or more connectors to communicate fluids with the patient's bonemarrow. Such kits may also include apparatus which allows monitoring apatient.

Kits incorporating teachings of the present disclosure may be rigid,semi-rigid or soft-sided. Such kits may provide a convenient way tocarry various components and devices operable to achieve vascular accessin an organized and systematic fashion. Such kits may present EMS firstresponders and other medical personnel with a well organized collectionof components and devices to achieve vascular access by placement ofperipheral intravenous (IV) catheters and/or intraosseous (IO)catheters. For some embodiments, a kit incorporating teachings of thepresent disclosure may be combination an IV kit, an IO kit and/or a unitclose kit in one convenient bag. Examples of various types of devicesand components which may be carried in a kit in accordance withteachings of the present disclosure are shown in FIGS. 7A-19.

Securing devices incorporating teachings of the present disclosure maybe provided in kits to allow easy removal and replacement of associateddrivers. Such securing devices may include a wide variety of cradles andother types of holders with relatively rugged snap-in features toprevent undesired release of a driver from an associated securingdevice. Securing devices may be formed from plastic and/or glasscomposite materials to provide durability for repeated replacement anduse of an associated driver. Such securing devices may releasably holdan associated driver in place within a kit so that the driver does notinterfere with other devices and components disposed in the kit. Asecuring device may be positioned in a kit to clearly present anassociated driver to a user during consideration of alternate vascularaccess routes.

Securing devices incorporating teachings of the present disclosure maymake it easy for a user to extract an associated driver from a kit usingonly one hand. Other components such as penetrator assemblies and IOneedles may be conveniently located in the kit to further minimize timeand manipulations required for a user to attach an IO needle and insertthe IO needle at a desired site in a patient. Such securing devices mayalso provide an easy site to return the driver to the kit after use. Theassociated driver may snap into place to securely protect the driveragainst accidental deployment until required for use in providinganother IO access.

Kits incorporating teachings of the present disclosure may be used inlocations where ruggedness and durability are of paramount importance.Such kits may be washable, water proof, temperature resistant, and/orcrush proof. Such kits may have a wide variety of different shapes andcolors. Kits incorporating teachings of the present disclosure may beany size as required to contain selected IO devices and IV devices whichmay be used to obtain, vascular access. In some embodiment kits may beapproximately ten inches in length by six to eight inches in width.

For some applications kits incorporating teachings of the presentdisclosure may be designed for use in military applications. Such kitmay be as compact as feasible with components disposed in one or morecompartments as necessary for an efficient use of space. Such kits mayalso include a manual intraosseous driver and related intraosseouscomponents to access a patient's vascular system. Such kits may includeintraosseous catheters, intravenous catheters, containers with sterilenormal saline, tourniquets and IO/IV securing devices. Variouscomponents may be configured for particular branches of the military,e.g., Army, Navy, Air Force, Coast Guard and Special Forces.

Another benefit of the present disclosure may include forming a kit withone or more dividers having components and devices arranged in order onpage one and page two corresponding with steps of a procedure such astreating a patient with an emergency condition or treating a patient fora chronic condition. The pages in a kit may be arranged to accommodate awide variety of procedures. For example, if a kit will be used in anoncology related application or for treatment of other chronicconditions, the “pages” in the kit may be arranged based on the stepsrequired to provide access to a patient's vascular system and to carryout a planned treatment.

Various techniques and procedures may be used to position and securelyengage a supporting structure for an IO device at an insertion site. Forsome applications, various types of straps may be used. See FIGS. 8 and11-17. Alternatively, various types of medical grade tape and adhesivematerials (not expressly shown) may be used. Also, Velcro strips may beused (see FIGS. 15 and 16).

Some features and benefits of the present disclosure may be describedwith respect to kit 20 (See FIGS. 1A, 1B, 2) and kit 20 a (See FIG. 6)and kit 120 (See FIGS. 7A and 7B). However, the present disclosure isnot limited to kits with designs, features and/or contents as shown inFIGS. 1A-19.

For some applications kits 20, 20 a and/or 120 may he semi-rigid or softsided. Kits 20, 20 a and 120 may be formed from a wide variety ofmaterials including, but not limited to, nylon cordura type materials,various types of polymeric and plastic materials. For some applicationskits 20, 20 a and/or 120 may be formed from relatively soft materialseach as canvas, polyesters and similar materials. For other applicationskits incorporating teachings of the present disclosure may be relativelyrigid and formed from materials such as lightweight aluminum alloys andsimilar hard materials.

For embodiments such as shown in FIGS. 1A-2A and 6 kits 20 and 20 a maybe formed using compression molded techniques. For other applications,kits 20 and 20 a may be formed with a foam liner having desiredconfiguration and dimensions with an outer layer of sewn fabric. Suchfoam liners may be designed to protect the contents carried in theresulting kit from being damaged or crushed. Other alternative low-costand reliable manufacturing techniques may be satisfactorily used to formkits in accordance with teachings of the present disclosure.

For some applications, kits 20 or 20 a may be generally described as atwo part molded case formed at least in part by compression moldingethylene vinyl acetate (EVA) foam. EVA may be generally described as apolymeric material with some of the characteristics of elastomericmaterials and some characteristics of thermal plastic materials. Howeverkits incorporating teachings of the present disclosure may be formedfrom a wide variety of polymeric materials, elastomeric materials and/orthermoplastic materials.

Kits 20 and/or 20 a may have a nominal wall thickness of approximately0.19 inches. Exterior surfaces of kits 20 and/or 20 a may be covered bya durable layer of heavy dinear polyester or other suitable material.Interior portions of kits 20 and/or 20 a may be formed in part byrelatively smooth layers of urethane or relatively smooth layers ofpolyvinyl chloride (PVC). Such materials allow interior portions of kits20 and/or 20 a to be more easily cleaned, particularly after use duringan emergency at a field location.

Kits 20 and/or 20 a may have two segments or enclosures 22 and 24 withgenerally hollow, rectangular configurations and compatible dimensions.As a result first segment 22 and second segment 24 may be releasablyengaged with each other to form an enclosure having desired dimensionsand configurations to efficiently carry IO and IV devices and componentsassociated with kits 20 and 20 a. For some applications, first segment22 and second segment 24 may have approximately the same dimensions andconfigurations such that each segment 22 and 24 may form approximatelyone-half of the resulting kit. For applications such as shown in FIGS.1A-2A and 6, first segment 22 may have a greater height or depth ascompared with second segment 24. Interior portions of first segment 22may be sized to contain intravenous fluid bags, intravenous tubing andextension tubing, various types of connectors, syringes see Lidocaine orother anesthetizing agents.

For purposes of describing various features of the present disclosure,first segment 22 may be described as having generally rectangular bottomlayer or base 30 with respective pairs of walls 34 and 36 extendingtherefrom. Bass 30 may also include first surface or interior surface 31(See FIGS. 2A and 6) and a second, exterior surface (not expresslyshown). One wall 34 a of kit 20 a may be modified as compared tocorresponding wall 34 of kit 20. Wall 34 a will be discussed later inmore detail. Generally rounded corners 38 may be formed between adjacentwalls 34 and 36.

Second segment 24 may be defined in part by top layer or cover 40.Sometimes top layer 40 may also be referred to as a lid. Top layer 40may include first surface or interior surface 41 (See FIGS. 2A and 6)and second surface or exterior surface 42 (See FIG. 1A). Respectivepairs of walls 44 and 46 may extend from top layer 40. Respectiverounded corners 48 may be formed between adjacent walls 44 and 46.

For some applications, a pair of zippers 28 and 29 may be used toreleasably engage second segment 24 with first segment 22 whenassociated kits 20 or 20 a is in their respective first, closedposition. (See FIG. 1A). For other applications a single zipper may besatisfactorily used. For some applications a fluid seal (not expresslyshown) may be formed when the perimeter of first enclosure 22 is engagedwith the perimeter of second enclosure 24 when kits 20 and/or 20 a arein their first, closed position.

First segment 22 and second segment 24 may be hinged with each otheralong one side of respective kits 20 and 20 a. Fabric type hinge 58 orother suitable low cost, reliable hinge mechanism may be used to allowmovement of second segment 24 relative to first segment 22 to open andclose the associated kit 20 or 20 a. Handle 26 may be attached withexterior portion of kits 20 and 20 a opposite from the hinge 58 locatedon interiors of kits 20 and 20 a. Handle 26 may be formed fromlightweight, durable web type material or any other suitable material.

Zippers 28 and 29 may be moved around the three edges of contact betweenfirst enclosure 22 and second enclosure 24 to engage and disengageadjacent portions of enclosures 22 and 24. Zippers 28 and 29 andassociated zipper mechanisms may be formed from durable, rustproofmaterial and extend along three edges of contact between first enclosure22 and second enclosure 24.

After kits 20 and/or 20 a have been used at a field location or at amedical facility, the used kit may be returned to a central location forcleaning and replacement of any missing components or devices. For someapplications breakable seal 23 (See FIG. 1B) may be engaged with zippers28 and 29 to indicate that the associated kit 20 or 20 a has beencleaned, inspected, any missing components or devices replaced and isnow ready to be used to provide access to a patient's vascular system.

One or more panels or dividers may be disposed within kits incorporatingteachings of the present disclosure. The dividers may also be referredto as “boards.” For embodiments represented by kits 20 and 20 a one edgeof each divider 50 may be engaged with associated hinge 58 to allowrotating movement of each divider 50 relative to hinge 58 whenassociated kit 20 or 20 a is in its first, open position.

Dividers 50 may be formed from polyvinyl chloride (PVC) or othersuitable materials. Each divider 50 may have a generally rectangularconfiguration with dimensions compatible with nesting each dividerwithin segments 22 and 24 when associated kit 20 or 20 a is in itsfirst, closed position. For some applications dividers 50 may be about0.050 to 0.060 inches thick. The width and other characteristics ofhinge 58 may also be selected to accommodate nesting of each divider 50within segments 22 and 24 when associated kit 20 or 20 a is in itsfirst, closed position.

Each divider 50 may also include first surface 51 and a second surface52. Surfaces 51 and 52 may sometimes be referred to as “pages.” Forembodiments such as shown in FIGS. 2A, 2B and 6, first surface 51 orpage 1 and second surface 52 or page 2 may include a plurality ofholders such as elastic straps or bands 54 and pockets 56. Velcro typestraps, holders and elastic bands may also be used.

For example, “page one” or first surface 51 of divider 50 may presentEMS personnel with devices, components and instructions used to selectand clean a site for vascular access. Such components and devices mayinclude containers 62 with cleaning fluids, alcohol wipes or other prepmaterials, flashlight 64 and a tourniquet (not expressly shown). Writteninstructions for selecting an insertion site and/or locating a vein maybe provided in pockets 56 on page one.

“Page Two” or second surface 52 of divider 50 may include devices andcomponents that allow EMS personnel to access a patient's vascularsystem via a peripheral vein or an intraosseous route. Such componentsmay include intravenous catheters, intraosseous needles and othercomponents that may be used to access a patient's vascular system. Asshown in FIG. 2B, one or more containers 230 with respective IO devicesdisposed therein may be releasably engaged with second surface 52 orpage two of divider 50. One or more IV devices such as IV needle sets136 may also be releasably engaged with second surface 52. Each IVneedle set 136 may include a syringe, IV needle and cover for the IVneedle.

For some applications, interior surface 41 of cover 40 may also functionas page three with additional devices, components and instructionsattached thereto. For example, when kits 20 and/or 21 a are used in anemergency environment to provide IO access to a patient, interiorsurface 41 or page three may include devices and components used tosecure and intraosseous device and/or an IV device at the insertion siteand to further prepare the patient for movement to an EMS treatmentfacility. Components and devices such as tape, dressing materials, anarm-board or splint and other components operable to secure a catheteror an intraosseous line may be provided on page three. Various types ofstraps and supporting structures for IO devices may be releasablyattached to page three or interior surface 41. See some examples inFIGS. 8-17.

Outside pocket 60 formed from mesh type material may be attached toexterior surface 42 of cover 40. Outside pocket 60 may hold printedreference materials such as quick reference cards. For some applicationselastic cords (not expressly shown) may also be provided on exteriorportion of kits 20 and 20 a to hold such materials.

Velcro or elastic strips or loops or any other fastening device pay beused to position components on dividers 50. In lieu of dividers 50, IOand IV devices and related components may be configured in some otherarrangement or organizing mechanism such as compartments or smallercontainers carried in a kit.

A device for accessing an intraosseous space such as a powered driver(See FIG. 4) or a manual driver (See FIGS. 18 and 19) may be carried infirst segment 22. For some applications a securing device such as shownin FIGS. 2A, 3, 5 and 6 may be disposed within first segment 22 toreleasably hold a driver. For other applications a powered driver and/ormanual driver may be placed in a collapsible bag or pouch and placedwithin first segment 22 or other portions of kit 20 and/or 20 a. Forstill other applications a powered driver and/or manual driver may becarried in a bag or pouch attached to exterior portions (not expresslyshown) of kit 20 and/or 20 a.

Powered driver 200 may include housing 202 with various types of motorsand/or gear assemblies disposed therein (not expressly shown). Arotatable shaft (not expressly shown) may be disposed within housing 202and connected with a gear assembly. Various types of fittings and/orconnectors may be disposed proximate one end of the rotatable shaftextending from end 204 of housing 202. For some applications a pin typefitting or connector such as drive shaft 218 may be used. A matching boxtype fitting or connector receptacle may be provided on an intraosseousdevice such that power driver 200 may be releasably engaged with theintraosseous device. For some applications, drive shaft 216 may have apentagonal shaped cross section with tapered surfaces formed on theexterior thereof. Fittings and/or connections with various dimensionsand configurations may be satisfactorily used to releasably engage anintraosseous device with a powered driver.

Container 230 as shown in FIGS. 2B and 18B may include lid 232 alongwith associated tab 234. Tab 234 may be configured to be flipped openwith one or more digits of an operator's hand. With lid 232 open, anoperator may releasably engage a driver with an IO device disposed incontainer 230. For example, drive shaft 216 of powered driver 200 may bereleasably engaged with box type connector or receptacle 258 ofpenetrator assembly 240. See FIGS. 4 AND 18A. Flexible strap 236 may beused to retain lid 232 with container 230 after lid 232 has been opened.

Handle 206 may include a battery (not expressly shown) or other powersource. Handle 206 may also include trigger assembly 208 for use inactivating powered driver 200. Examples of powered drivers are shown inpending patent applications Ser. No. 10/449,503 filed May 30, 2003entitled apparatus and Method to Provide Emergency Recess To BoneMarrow, Ser. No. 10/449,476 filed May 30, 2003 entitled Apparatus andMethod to Access Bone Marrow and Ser. No. 11/042,912 filed Jan. 25, 2005entitled Manual Interosseous Device.

Various types of intraosseous devices, intraosseous needles and/orpenetrator assemblies may be carried in a kit incorporating teachings ofthe present disclosure. See for example FIG. 2B. Intraosseous devices160 and 160 a which are shown in FIGS. 8, 11, 12 and 13 may be carriedin a kit along with powered driver 200 and inserted into a patient'sbone marrow in accordance with teachings of the present disclosure.

For some applications a securing device designed to accommodate one ormore specific types of drivers may be disposed within first segment 23.For other applications more generic types of holders or cradles may beplaced within first segment 22. For embodiments such as shown in FIGS.2A, 3, 5 AND 6 securing device or cradle 80 may be designed toaccommodate powered drivers such as powered driver 200. Cradles andholders incorporating teachings of the present disclosure may befabricated from a wide variety of thermoplastic and/or polymericmaterials filled with glass fibers.

Length 82 and width 84 of cradle 80 may be selected to be compatiblewith interior dimensions of first enclosure 22 and similar dimensionsassociated with a driver that will be releasably engaged with cradle 80.For some applications first end 86 and second end 88 may have generallyrounded configurations. Notch 90 may be formed in first end 86 toaccommodate drive shaft 216 extending from end 204 of power driver 200.

First longitudinal edge 91 and second longitudinal edge 92 may be spacedfrom each other and extend generally parallel with each other betweenfirst end 86 add second end 88. For some applications, ends 86, 88 andlongitudinal edges 91, 92 may fit flush with interior surface 31 ofbottom layer 30. Maintaining close contact between interior surface 31and adjacent portions of cradle 80 may substantially reduce or minimizeproblems associated with cleaning an associated kit after use,particularly after used during an emergency at a field location.

Various types of holders clamps and/or quick release mechanisms may beprovided on a cradle incorporating teachings of the present disclosure.For embodiments represented by cradle 80 a pair of arms 94 and 96 mayproject from respective longitudinal edges 91 and 92 . Arms 94 and 96may be relatively strong with sufficient flexibility to allow insertingand removing portions driver 200 from engagement with cradle 80. Theheight of arms 94 and 96 relative to longitudinal edges 91 and 92 may bebased at least in part on the height or depth of first enclosure 22 andcorresponding dimensions of driver 200. Support surface 98 may bedisposed between arms 94 and 96 in an elevated position relative tolongitudinal edges 91 and 92. The location of support surface 98 may beselected to accommodate corresponding dimensions of driver 200 andparticularly handle 206.

The spacing or gap formed between first arm 94 and second arm 96 may beselected to accommodate the width of handle 206 of driver 200.Respective ribs 100 may be formed approximate the end of each arm 94 and96 opposite from longitudinal edges 91 and 92. Ribs 100 preferablyextend inwardly relative to associated arm 94 and 96. The dimensions ofarms 94 and 96, the gap formed therebetween, and associated ribs 100 maybe selected to be compatible with forming a snug but releasable snaptype fit with adjacent portions of handle 206 of driver 200.

For some applications first wall 104 and second wall 106 may be disposedbetween first end 86 and supporting surface 98 such as shown in FIG. 3.The spacing between first wall 104 and second wall 106 may be selectedto correspond with corresponding dimensions of handle 206 of driver 200and particularly dimensions associated with trigger assembly 208. Walls104 and 106 may cooperate with each other to provide a “trigger guard”to prevent accidental activation of driver 200 when kit 20 and/or 20 aare in their first, closed position.

One or more holes 108 may be formed in cradle 80 approximate first end86 and second end 88. Holes 108 may be sized to receive various types offasteners such as rivals and/or screws (not expressly showed). Suchfasteners may be used to secure cradle 80 at a desired location withinfirst enclosure 22.

Materials used to form cradle 80 may be relatively low cost but mustalso have sufficient durability for repeated insertion and removal of anassociated driver. For some applications arms 94 and 96 may be designedto allow insertion and removal of an associated driver at lease fivehundred times. Arms 94 and 96 may also have sufficient stiffness andstrength to allow associated driver 200 to snap into place. Thestiffness of arms 94 and 96 may be selected such that driver 200 willnot be inadvertently released from cradle 80 if kit 20 or 20 a should bedropped or otherwise mishandled.

For embodiments such as shown in FIG. 6, second end 88 (not expresslyshown) of oracle 80 a may be modified to include electrical contactsused to change a battery or other power source disposed in handle 206 ofdriver 200. Electrical connector assembly 70 may be disposed on exteriorportions of wall 34 a to accommodate inserting charging cable 72extending from an appropriate charger (not expressly shown). Lights 74and 76 may be provided as part of electrical connector assembly 70 toindicate the status of a battery or other paper source disposed inhandle 206 after each use of powered driver 200 and to indicate thestatus of recharging powered driver 200.

Various types of indicator lights may be used. For some applicationslight 74 may be yellow to indicate that a battery (not expressly shown)in power driver 200 needs to be recharged. Light 76 may be green toindicate that the charging is not required or that charging ofassociated powered driver 200 has been satisfactorily completed. Forsome applications, kit 20 a will preferably be in its first, openposition during charging Of powered driver 200.

Prehospital and combat situations are often ideally suited to use “unitdose” containers of various types of medications. Emergency medicalpersonnel often need only a one-time dose of medication, such as anantidote for poison or epinephrine to stabilize the patient. Unit doseampules are widely used by paramedics to give a predetermined amount ofmedication for a particular indication. A limited number of drugs maysatisfactorily fill such needs.

Kit 120 as shown in FIGS. 7A and 7B represents one example of a kitcontaining unit dopes in accordance with teachings of the presentdisclosure. For some applications, kit 120 may be carried separate frompreviously discussed kits 20 and 20 a. For other applications kit 120may be disposed within kits 20 and/or 20 a. Kit 120 is shown, in FIG. 7Bin its second, open position with cover 140 removed to provide access toampules 123-127 containing respective unit doses of medication.

Kit 120 may include base portion 130 and cover 140. Zipper 122 or othertypes of closures may be satisfactorily used to releasably engage cover140 with base portion 130. For some applications a pair of zippers and abreakable seal such as shown in FIG. 1B may be used with kit 120. Kit120 is shown in FIG. 7A in its first, closed position with cover 140releasably engaged with base portion 130.

For embodiments such as shown in FIGS. 7A and 7B, kit 120 may bedescribed as having a generally rectangular configuration with roundedcorners. Cover 140 may be generally described as a hollow enclosuredefined in part by top layer 142 with four (4) walls extendingtherefrom. Walls 143 and 144 are shown in FIG. 7A. Interior portions ofcover 140 are preferably open to accommodate storage of ampules 123-127.

Base 130 may be formed from a relatively thick layer of materialsatisfactory for use. A plurality of holes may be formed in interiorsurface 132 of base 130 satisfactory to accommodate releasably storingeach ampule 123-127 in a respective hole. The exterior configurations ofbase 130 may also be defined in part by walls and rounded corners whichare preferably compatible with the walls and rounded corners associatedwith cover 140.

Base portion 130 as shown in FIG. 7B may function as a rack releasablyholding a plurality of single use (unit dose) ampules which may meetmany (if not most) of an emergency medical service provider's immediateneeds. For example, ampule 123 may contain epinephrine for cardiacarrest and life threatening allergies. Ampule 124 may contain atropinefor cardiac arrest and chemical exposures. Ampule 125 may containdiazepam for seizures and emergency sedation. Ampule 126 may containamiodarone for cardiac arrhythmias. Ampule 127 may contain narcan fordrug overdose. Each ampule 123-127 may be clearly labeled so that anappropriate drug may be quickly and accurately selected in an emergency.As shown in FIGS. 7A and 7B, kit 120 may contain medications in an easyto carry and maintain rack or stand such as base 130. Kit 120 mayinclude zip lock cover 140 which is easy to remove in an emergency.

The ability to satisfactorily insert an IO device such as an IO needleat a desired insertion site may be problematic when a patient is movingor has the potential to move. Inserting an IO device in the wrong placemay expose a patient to potential harm. Patient movement may be ofspecial concern for patients suffering from status epilepticus orviolent patients (drug overdoses or mental status changes) that need tobe controlled for their safety and treatment. Epileptic patients mayshake violently for prolonged periods which makes starting aconventional IV nearly impossible. Likewise, it may be difficult toaccurately place an IO device at a desired insertion site in thesepatients. Although target areas for successful IO placement such as apatient's tibia and humerus are often larger than target areas forplacement of an IV device, problems with inserting an IO device at adesired insertion site may be minimized by using stabilization devicesand supporting structures incorporating teachings of the presentdisclosure. Such devices and supporting structures may be easy to apply,even in difficult field environments.

FIGS. 8, 11, 12, 13, 14 and 17 show various examples of an intraosseousdevice inserted into a patient's bone marrow to provide vascular accessin accordance with teachings of the present disclosure. Bone 152 andassociated bone marrow 154, shown in FIGS. 8, 11, 12, 13, 14 and 17, maybe representative of the tibia in a patient's leg. The upper tibiaproximate a patient's knee may often be used as an insertion site for IOaccess to a patient's vascular system. A humerus may also be used as aninsertion site for IO access to a patient's vascular system.

FIG. 8 shows one example of an intraosseous device which may have beeninserted into a patient's bone marrow using a kit containing variousdevices and components in accordance with teachings of the presentdisclosure. For this example, intraosseous device 160 may be generallydescribed as intraosseous (IO) needle 160 having a hollow, longitudinalbore extending therethrough (not expressly shown). IO devices 160 may bereleasably attached to page 2 of kits 20 and/or 20 a.

First end or tip 161 of IO needle 160 may be designed to drill or outthrough bone 152 and penetrate associated bone marrow 154. Tip 161 maybe open to allow communication of fluids with bone marrow 154. Also, oneor more side ports 164 may be formed in IO needle 160 to allowcommunication of fluids therethrough. Second end 162 of IO needle 160may have various types of connections including, but not limited to, aconventional Luer lock connection (not expressly shown) associated withsupplying IV fluids and medications to a patient.

Strap 170 and supporting structure 180 such as shown in FIGS. 8 and 9may be carried in a kit in accordance with teachings of the presentdisclosure. Strap 170 may be formed from various types of elastomericand/or nonelastomeric materials compatible with contacting skin 156 andother soft tissue covering a patient's bone at a selected insertionsight. The dimensions and configuration of strap 170 may be selected toform satisfactory engagement with adjacent portions of leg 150, an arm,or other desired sites for providing IO access to a patient's vascularsystem.

Strap 170 may include first end 171 and second end 172 sized to beinserted through holes 181 and 182 of supporting structure 180. Strap170 and supporting structure 180 cooperate with each other to preventaccidental removal or withdrawal of IO needle 160 from an insertionbite. Strap 170 and supporting structure 180 also cooperate with eachother to prevent excessive movement or rocking of IO needle 160 relativeto the insertion site.

Supporting structure 180 may include relatively short, hollow cylinder184 with a pair of flanges or wings 186 extending therefrom. Holes 181and 182 may respectively be formed in each wing or flange 186. Wings 186may be formed from relatively flexible material which will conform withadjacent portions of a patient's skin, soft tissue and bone. Hollowcylinder 184 may be formed from relatively rigid material to preventundesired movement of associated IO needle 160. Interior dimensions ofhollow cylinder 184 may correspond approximately with the exteriordimensions of IO needle 160 to provide a relatively snug fittherebetween.

For embodiments such as shown in FIG. 10, supporting structure 180 a mayinclude wings or tabs 186 a which have been modified to includerespective projections 181 a and 182 a extending there from. Strap 170 amay be modified as compared with strap 170 by attaching respectivebuckles 174 with first end 171 a and second end 172 a. Each buckle 174may include respective hole 176 sized to receive associated projection181 a and 182 a formed on tabs 186 a.

Supporting structure 180 a may be placed at an IO insertion site. Buckle174 a at first end 171 a of strap 170 a may be releasably engaged withcorresponding projection 181 a. Strap 170 a may then be extended aroundpatient's leg or other bone to allow engaging buckle 174 a at second end172 a with associated projection 182 a. For such applications, strap 170a may be formed from elastomeric material.

For some applications supporting structure 180 may be placed at aninsertion site prior to installing IO device 160. IO device 160 may thenbe inserted through the longitudinal bore of supporting structure 180.For other applications an IO device with exterior dimensions andexterior configuration of the IO device may be compatible with interiordimensions 188 of supporting structure 180 may first be installed at adesired insertion site. Supporting structure 180 may then be fitted overthe installed IO device (not expressly shown) by placing the IO devicethrough the longitudinal bore of supporting structure 180. Strap 170 amay then be engaged with respective projections 181 and 182.

FIG. 11 shows IO needle 160 inserted into bone marrow 154. Supportingstructure 180 b may be used to stabilize IO needle 160 and limitexcessive movement relative to bone 152. Supporting structure 180 b maybe generally described as having a domed shape configuration. Thedimensions of supporting structure 180 b may be selected to becompatible with a desired insertion site. A longitudinal bore or alongitudinal opening (not expressly shown) may extend through supportingstructure 180 b. The longitudinal bore may have dimensions compatiblewith exterior dimensions of IO needle 160. Supporting structure 180 bmay be formed from various types of semi-rigid silicone based materialsand/or materials satisfactory for providing required support. A pair ofholes (not expressly shown) may be provided in supporting structure 180b to accommodate the use of strap 170. However, other straps such asshown in FIGS. 10, 14 and 15 and/or adhesive materials (not expresslyshown) may be satisfactory used to position supporting structure 180 ata desired insertion site.

FIG. 12 shows IO 160 inserted into bone 152 add associated bone marrow154. Strap 170 may be placed around bone 152 and attached to supportingstructure 180 as previously described. Sensor 178 may be attached tostrap 170 for use in measuring various parameters associated withproviding fluids and/or medications through IO device 160 to bone marrow104. Such parameters may include, but are not limited to, pressureand/or changes in the size of a patient's leg, temperature and/or pulserate. When sensor 178 detects a preset value for one or more of theseparameters, an alarm may be sounded. For some applications sensor 178may be coupled with monitor 190 and/or a general purpose computer (notexpressly shown). The general purpose computer may include one or moreprograms operable to stop infusion of fluids and/or medication throughassociated IO device 160 in the event one or more parameters exceedspreset limits.

FIG. 13 shows IO device 160 a inserted into bone 152 and associated bonemarrow 154. IO device 160 a may be equipped with pressure transducer 192proximate tip 161 to measure intraosseous pressure. For someapplications, a similar needle (not expressly shown) may be placed in aleg muscle to measure intra-compartment pressure.

Seal assembly 195 may be used to isolate transducer wire 196 so thatinfusions of fluids may proceed while, at the same time, measuringintravenous pressure at tip 161. Measurements from sensor 192 may beanalyzed by a computer (not expressly shown) to manage changes in apatient's condition by initiating pre-set increases in infusionpressure, controlling the rate of infusion or stopping infusion alltogether and alarming the patient and/or medical personnel if pressurelimits are exceeded.

FIGS. 14, 15 and 16 show one example of a supporting structure or guidewhich may be disposed at a desired insertion site such as the uppertibia proximate a patient's knee. Supporting structure or guide 180 cmay be generally described as having a dome shaped configuration withcavity or recess 194 formed therein and sized to receive an intraosseousdevice. For example, recess 194 may be sized to accommodate anintraosseous device such as penetrator assembly 240. See for exampleFIG. 17.

Supporting structure or guide 180 c may be formed from various polymericand/or thermoplastic materials having desired rigidity and strength todirect insertion of an intraosseous device at a desired insertion site.Supporting structure 180 c may also be formed from various types ofelastomeric and/or nonelastomeric materials satisfactory for use informing a guide or supporting structure to direct insertion of anintraosseous device at a desired insertion site.

For some applications strap 170 c may include one or more strips of hookand loop type material 198 (sometimes referred to as Velcro® strips)disposed proximate first end 171 c and second end 172 c of strap 170 c.The configuration, size and dimensions of Velcro® strips 198 may bemodified to allow strap 170 c to releasably attach supporting structure180 c with a leg or other portions of a patient's body having variousdimensions. For some applications supporting structure 180 c may includetarget 199 disposed within recess 194 for use by an operator to moreprecisely direct insertion of an associated IO device at a desiredinsertion site.

FIG. 17 shows powered driver 200 being used to insert penetratorassembly 240 at an insertion site identified by guide or supportingstructure 180 c. Powered driver 200 may be further stabilized withvarious types of straps and/or medical grade tape (not expressly shown)prior to inserting penetrator assembly 240.

FIGS. 18A and 19 show examples of manual drivers which may be carried ina kit in accordance with teachings of the present disclosure. For someapplications, a kit may contain only a powered driver or only a manualdriver. For other applications, a kit incorporating teachings of thepresent disclosure may include both a powered driver and a manualdriver. Examples of manual drivers are shown in pending patentapplications Ser. No. 10/449,503 filed May 30, 2003 entitled Apparatusand Method to Provide Emergency Access To Bone Marrow and Ser. No.11/042,912 filed Jan. 25, 2005 entitled Manual Interosseous Device.

Manual driver 200 a may include handle 212 with drive shaft 216extending therefrom. Manual driver 200 a may also include an optionalratchet mechanism (not expressly shown). Handle 212 may be formed in avariety of shapes, such as with finger grips 214. Handle 212 may beformed from materials satisfactory for multiple uses or may be formedfrom materials satisfactory for one time or disposable use. Handle 212may have an ergonomically designed shape suitable for grasping with ahand and/or fingers during manual insertion of an IO device into boneand associated bone marrow.

FIG. 18A shows an exploded view of manual driver 200 a and penetratorassembly 240. Penetrator assembly 240 may include an outer penetratorsuch as a cannula, hollow tube or hollow drill bit and an innerpenetrator such as a stylet or trocar. Various types of outerpenetrators may be used to form a portion of penetrator assembly 210.Various types or stylets and/or trocars may be disposed within an outerpenetrator.

For some applications penetrator assembly 240 may include connecter 250with inner penetrator or trocar 260 extending therefrom and hub 270 withouter penetrator or cannula 280 extending therefrom. Connector 250 andhub 270 may be releasably engaged with each other using Luer typefittings, threaded connections or other suitable fittings formed onsecond end 252 of connector 250 and first end 211 of huh 270. Outerpenetrator 280 may extend from second end 272 of hub 270.

For some applications outer penetrator or cannula 280 may be describedas a generally elongated tube sized to receive inner penetrator orstylet 260 therein. Portions of inner penetrator 260 may be disposedwithin a longitudinal passageway 276 extending through outer penetrator280. The outside diameter of inner penetrator 260 and the insidediameter of longitudinal passageway 276 may be selected so that innerpenetrator 260 may be slidably disposed within outer penetrator 280.Outer penetrator 280 may be formed from stainless steel, titanium orother materials of suitable strength and durability to penetrate boneand magnetic characteristics to allow releasable engagement with disc254.

Tip 281 of outer penetrator 280 and/or tip 261 of inner penetrator 260may be operable to penetrate bone and associated bone marrow. Theconfiguration of tips 261 and/or 281 may be selected to penetrate a boneor other body cavities with minimal trauma. First end or tip 261 ofinner penetrator 260 may be trapezoid shaped and may include one or morecutting surfaces. In one embodiment outer penetrator 280 and innerpenetrator 260 may be ground together as one unit during an associatedmanufacturing process. Inner penetrator 260 may also include alongitudinal groove (not expressly shown) that runs along the side ofinner penetrator 260 to allow bone chips and/or tissues to exit aninsertion site as penetrator assembly 240 is drilled deeper into anassociated bone.

Hub 270 may be used to stabilize penetrator assembly 240 duringinsertion of outer penetrator 280 into a patient's skin, soft tissue andadjacent bone at a selected insertion site. First end 271 of huh 270 maybe operable for releasable engagement or attachment with associatedconnector 250. Second end 272 of hub 270 may have a size andconfiguration compatible with an associated insertion site. Thecombination of hub 270 with outer penetrator 280 may sometimes bereferred to as a penetrator set or an intraosseous needle.

For some applications connector 250 may be described as a generallycylindrical tube defined in part by first end 251 and second end 252.The exterior of connector 250 may include an enlarged tapered portionadjacent to end 251. A plurality of longitudinal ridges 256 may beformed on the exterior of connector 250 to allow an operator to graspassociated penetrator assembly 240 during attachment with drive shaft216. Longitudinal ridges 256 also allow connector 250 to be grasped fordisengagement from hub 270 after outer penetrator 280 has been insertedinto a bone and associated bone marrow. Disc 254 may be disposed withinreceptacle or opening 256 for use in releasably attaching connector 250with drive shaft 216.

For some applications disc 254 may be a magnet. For such applicationsdrive shaft 216 may be formed from various types of metallic materialswith magnetic characteristics compatible with releasable engagement ofdrive shaft 216 with the magnetic disc 254 disposed in penetratorassembly 240. For other applications a magnet (not expressly shown) maybe formed on the end of drive shaft 216. For such applications disc 254may be formed from various types of metallic material withcharacteristics compatible with releasably engaging penetrator assembly240 with the magnet formed on the end of drive shaft 216.

First end 271 may have a generally cylindrical pin type configurationcompatible with releasably engaging hub 270 with second end or box end252 of connector 250. Second end 252 of connector 250 may includeopening 258 sized to receive first end 271 of hub 270 therein. Threads259 may be formed in opening 258 adjacent to second end 252 of connector250. Threads 273 may be formed proximate end 271 of hub 270. Threads 259and 273 may be used to releasably attach connector 250 with first end271 of hub 270.

For some applications end 272 of huh 270 may have the generalconfiguration of flange. Angular slot or groove 274 sized to receive oneend of protective cover or needle cap 290 may be formed in end 272. Slotor groove 274 may be used to releasable engage cover 290 with penetratorassembly 240,. For some applications cover 290 may be described as agenerally hollow lube having rounded end 292. Cover 290 may be disposedwithin associated slot 24 to protect portions of outer penetrator 280and inner penetrator 260 prior to attachment with a driver. Cover 290may include a plurality of longitudinal ridges 294 formed on theexterior thereof. Longitudinal ridges 294 cooperate with each other toallow installing and removing cover or needle cap 290 withoutcontaminating portions of an associated penetrator. Cover 290 may beformed from various plastics and/or metals.

FIG. 18B shows container 230 with penetrator assembly 240 disposedtherein. One of the benefits of the present disclosure includesproviding a kit which allows an operator to remove a driver from aholder contained within the kit using one hand. The other hand of theoperator may remove container 230 from page two of divider 50 and openlid 232 of container 230 using one hand. Drive shaft 215 may bereleasably engaged with receptacle 258 in end 251 of connector 250.

FIG. 19 shows another example of a manual driver which may be used toinsert an IO device into bone marrow in accordance with teachings of thepresent disclosure. Manual driver 200 b may include pistol grin typehandle 212 b with drive shaft 216 extending therefrom. Manual driver 200b may also include an optional ratchet mechanism (not expressly shown).Manual driver 200 b may be releasably engaged with penetrator assembly240 or any other IO device incorporating teachings of the presentdisclosure.

Examples of acute and chronic conditions which may be treated usingkits, intraosseous devices, intravenous devices and proceduresincorporating teachings of the present disclosure include, but are notlimited to, the following:

-   -   Anaphylaxis (epinephrine, steroids, antihistamines, fluids, and        life support)    -   Arrhythmia (anti-arrhythmics, electrolyte balance, life        support);    -   Burns (fluid replacement, antibiotics, morphine for pain,        control);    -   Cardiac arrest (epinephrine, atropine, amiodarone, calcium,        xylocaine, magnesium);    -   Congestive heart failure (life support, diuretics, morphine,        nitroglycerin);    -   Dehydration (emergency port for life support, antibiotics,        blood, electrolytes);    -   Diabetic Ketoacidosis (life support, electrolyte control, fluid        replacement);    -   Dialysis (emergency port for life support, antibiotics, blood,        electrolytes);    -   Drug overdose (naloxone, life support, electrolyte correction);    -   Emphysema (life support, beta adrenergics, steroids);    -   Hemophiliacs (life support, blood, fibrin produces, analgesics);    -   Osteomyelitis (antibiotics directly into the site of infection,        analgesics);    -   Pediatric applications (shock, dehydration, nutrition,        electrolyte correction);    -   Seizures (anti-seizure medications, life support, fluid        balance);    -   Shook (life support fluids, pressor agents, antibiotics,        steroids);    -   Sickle cell crisis (fluid, morphine for pain, blood,        antibiotics);    -   Trauma (emergency port for life support fluids, antibiotics,        blood, electrolytes);

More than 35,000 Advanced Cardiac Life Support (ACLS) ambulances are inservice in the U.S. Each is equipped with emergency drugs and devices.Most are required to carry intraosseous needles and paramedics aretrained in their use for pediatric emergencies. Kits incorporatingteachings of the present disclosure may be used so administermedications and treats before permanent damage to a patient occurs.

More than 4,000 emergency rooms in the U.S. are required to treatlife-threatening emergencies like shock trauma and cardiac arrest. ERsare stocked with the latest devices and equipment to help patientsreceive state-of-the-art treatment. However, there is no moreexasperating situation for the physician or potentially catastrophiccondition for the critical patient, than the inability to establishintravenous access. Kits with IO devices incorporating teachings of thepresent disclosure may provide a simple and straightforward solution forextremely difficult clinical problems.

Hospitals are required to provide crash carts on every patient ward. Itis estimates that 6,000 U.S. hospitals stock more than 60,000 crashcarts. These crash carts are stocked with defibrillators, IV accessdevices, including central venous catheters, IV fluids and drugs forcommon emergencies. Nurses and other healthcare workers using thosecrash carts are often inexperienced in such emergencies and havedifficulty establishing IV access. A kit with IO devices incorporatingteachings of the present disclosure may provide the long sought IValternative for difficult patients.

Automatic injectors are widely used in the military. During DesertStorm, combat soldiers carried an atropine auto-injector for nerve gaspoisoning. Current auto-injectors are limited to intramuscularinjections. The Kits with IO devices may vastly expand the scope oftreatment to include intravenous drugs, without having to be skilled inthe technique of intravenous insertion.

Most acute care hospitals in the U.S. operate Intensive Care Units(ICUs) for seriously ill patients. Establishing and maintaining venousaccess in these patients is often a challenge. IO access may be awelcome procedure for administration of drugs and fluids to thesecritical patients.

Ten percent of the population experience a major seizure in theirlifetime and more than 2,500,000 people in the United States haveepilepsy. Grand mal seizures represent one of the most dramatic eventsin medicine. During the seizure, which usually lasts 60 to 90 seconds,patients typically fall to the ground, become rigid with trunk andextremities extended, and shake violently. The most dreaded progressionof seizures is status epilepticus, a condition defined as a continuousseizure lasting more than 30 minutes or two or more seizures that occurwithout full conscious recovery between attacks. Convulsive statusepilepticus requires urgent, immediate treatment. Patients are at riskfor serious injury, hypoxemia, circulatory collapse, permanent braindamage and death. The overall mortality of convulsive status epilepticusis up to 33 percent.

Intravenous access with a large bore needle/catheter must be establishedto administer anticonvulsant medications. These include a benzodiazepinefollowed by phenytoin and/or phenobarbitol for immediate seizure controland prevention of further seizures. There are no satisfactory oral,rectal, or intramuscular medications that will control statusepilepticus.

The problem facing clinicians and paramedics treating patients withstatus epilepticus is the difficulty establishing venous access. Withoutadequate venous lines none of the effective anticonvulsants can begiven. During seizures the violent shaking makes accessing asatisfactory vein difficult. Often after the line is established,further shaking dislodges the IV or causes it to infiltrate.

Further, caregivers are at great risk of puncturing themselves with aneedle when attempting to establish venous access in a patient during aseizure. Through no fault of their own, seizing patients, by jerking andthrashing around, turn the safest procedure into a terrifying venture.Doctors, nurses, and paramedics work in mortal fear of contracting AIDSand hepatitis through an inadvertent puncture with a contaminatedneedle.

In an attempt to solve the venous access problem, emergency physiciansand intensivists have turned to establishing a central line (intravenouscatheter placed in a large central vein such as the subclavian orfemoral vein). However, with this method, even under ideal conditions,there is an increased incidence of serious side effects such aspneumothorax, hemothorax, inadvertent puncture of a major artery,infection, venous thrombosis, and embolus. In the case of a patient withstatus epilepticus, this method becomes increasingly difficult anddangerous for all of the above-mentioned reasons. Therefore, mostdoctors are reluctant to even attempt a central line until seizures haveceased.

Dialysis patients who often come to the emergency room in lifethreatening situations such as pulmonary edema (water on the lungs) orhigh potassium, leading to cardiac arrest. These patients typically havetroublesome or non-existent veins. The IO access may give these patientshope for a better quality of live and decrease their mortality.

Drug overdose victims, often comatose, generally require immediate IVaccess to give antidotes and life saving medications such as Narcan.These patients usually have difficult venous access due to long termabuse of their veins. IO access may give these patients an alternateroute for delivery of medications and fluids while improving the safetyof the healthcare workers.

Trauma victims and attempted suicide patients, often in shock due toblood loss, may also require swift replacement of fluids to save vitalorgans. Because of the shock condition (decreased blood pressure), veinscollapse and are often impossible to find. IO access may save preciousminutes for paramedics and trauma surgeons responsible for their care.

Although the present disclosure and its advantages have been describedin detail, it should be understood that various changes, substitutionsand alternations can be made herein without departing from the spiritand scope of the invention as defined by the following claims.

1-21. (canceled)
 22. A vascular access kit comprising: components foraccessing a peripheral vein; components for accessing bone marrow at aselected intraosseous site, the components for accessing bone marrowcomprising: a penetrator; and a powered driver having a body and ahandle; and a cradle configured to secure and releasably engage thepowered driver in a predetermined position, wherein the cradle preventsan activation of the powered driver when the powered driver is securedin the cradle in the predetermined position.
 23. The kit of claim 22,wherein the penetrator comprises an intraosseous needle set.
 24. The kitof claim 22, wherein the kit further comprises at least one divideroperable to releasably hold in an organized sequence an intravenousaccess device and an intraosseous access device.
 25. The kit of claim22, wherein the powered driver is configured to insert the penetratoralong a first axis extending through the body, wherein the handleextends from the body at a non-parallel angle to the first axis, whereinthe first axis extends through a notch formed in a base of the cradlewhen the powered driver is secured to the cradle in the predeterminedposition.
 26. The kit of claim 22, wherein the cradle is configured toprevent securement of the powered driver in a position other than thepredetermined position.
 27. The kit of claim 22, wherein the cradlecomprises walls with dimensions corresponding to dimensions of at leasta portion of the powered driver, wherein the wails as dimensioned areconfigured to prevent an engagement of the powered driver in a positionother than the predetermined position.
 28. The kit of claim 27, whereinthe powered driver comprises a trigger assembly, wherein the walls ofthe cradle are configured to prevent the trigger assembly from beingactivated.
 29. The kit of claim 22, wherein the cradle comprises a firstend and a second end, wherein the handle of the powered driver isadjacent to the first end of the cradle in the predetermined position.30. The kit of claim 29, wherein the first end of the cradle iscorrespondingly dimensioned to secure the body of the powered driver.31. The kit of claim 30, wherein the first end of the cradle asdimensioned is configured to prevent securement of the handle of thepowered driver.
 32. A kit for accessing the vascular system of a patientcomprising: an intravenous (IV) access device and an intraosseous (IO)access device comprising: a penetrator; and a powered driver having abody and a handle; a cradle attached to an interior surface of the kitand configured to secure and releasably engage the powered driver in apredetermined position, wherein the cradle prevents an activation of thepowered driver when the powered driver is secured in the cradle in thepredetermined position.
 33. A kit of claim 32, further comprising: adivider disposed in the kit with the penetrator releasably engaged withone surface of the divider; and the penetrator operable to be releasablyengaged with the powered driver.
 34. A kit of claim 32, wherein thecradle is configured to allow a user to easily grasp the handle of thepowered driver and remove the powered driver from the cradle.
 35. Thekit of claim 32, wherein the powered driver is configured to insert thepenetrator along a first axis extending through the body, wherein thehandle extends from the body at a non-parallel angle to the first axis,wherein the first axis extends through a notch formed in a base of thecradle when the powered driver is secured to the cradle in thepredetermined position.
 36. The kit of claim 32, wherein the cradle isconfigured to prevent securement of the powered driver in a positionother than the predetermined position.
 37. The kit of claim 32, whereinthe cradle comprises walls with dimensions corresponding to dimensionsof at least a portion of the powered driver, wherein the walls asdimensioned are configured to prevent an engagement of the powereddriver in a position other than the predetermined position.
 38. The kitof claim 37, wherein the powered driver comprises a trigger assembly,wherein the walls of the cradle are configured to prevent the triggerassembly from being activated.
 39. The kit of claim 32, wherein thecradle comprises a first end and a second end, wherein the handle of thepowered driver is adjacent to the first end of the cradle in thepredetermined position.
 40. The kit of claim 39, wherein the first endof the cradle is correspondingly dimensioned to secure the body of thepowered driver.
 41. The kit of claim 40, wherein the first end of thecradle as dimensioned is configured to prevent securement of the handleof the powered driver.